neobookRx
DrugsLevel 4 LocalisationS1/S2OPDEML

Sodium Cromoglycate

Mast cell stabiliserAnti-inflammatory

Indications

Registered South African indications:

  • Allergic conjunctivitis

Cautions

Contraindications

South African recommendations & Recommendations in other jurisdictions

  • Hypersensitivity to sodium cromoglycate, benzalkonium chloride or to any of the excipients

Cautions

  • Pregnancy
  • Breastfeeding
  • Concomitant use of soft contact lenses
  • Extensive ocular surface disease

Adult dosage

Forms avail. in SA and covered in this monograph: opd

Dosages below include:

  • South African registered indications and dosages

South African registered indications and dosages

Prevention and treatment of allergic conjunctivitis

  • Ophthalmic (opd): 1-2 drops into each eye(s), 4 times daily

It is important that the regular administration of sodium cromoglycate is maintained in the prevention and treatment of allergic conjunctivitis as therapy is essentially prophylactic


The solution should be discarded 1 month after first opening the bottle or if any turbidity develops


Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their medical practitioner’s advice concerning the continued use of sodium cromoglycate. There have been reports of baterial keratitis associated with the use of topical ophthalmic products

Paediatric dosage

See adult dosage

Special populations

Pregnancy

  • Caution
  • Cromoglicic acid should be used cautiously during pregnancy. The widespread use of sodium cromoglycate has yet to reveal any adverse effects to mother or child during pregnancy

Breastfeeding

  • Caution
  • It is not known whether sodium cromoglycate is excreted in human breast milk but on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest that the use of sodium cromoglycate has any undesirable effects on the baby

Renal Impairment

Hepatic Impairment

Elderly

Porphyria Information

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Immune, Blood and Lymphatic System Disorders

  • Hypersensitivity reactions

Sensory Disorders

  • Transient stinging and burning
  • Local irritation

Interactions

No information available

Monitoring

None routine. Specific cases may require

  • Ophthalmic examination

Mechanism of action

Cromoglicic acid inhibits the release of allergy mediators by stabilising the membranes of sensitised mast cells.

Dosage forms

  • Eye drops

Formulation

Eye drops (per ml) 20mg

  • Bausch & Lomb Vividrin Eye Drops (Soflens) originator
  • Stop-Allerg Eye Drops (Genop)
  • Cromohexal Eye Drops (Sandoz)

Also available in the following form: Nasal spray.

References

1. SAMF_12th Edition_Page 582 2. SmPC: Vividrin eye Drops 2%, Bausch & Lomb: Last updated on eMC: 20 Sep 2007; Downloaded online 19 Nov 2018 [https://drive.google.com/drive/u/0/folders/1f5LL9cR3RZIiFcqbP8n_NKfQxDg8ce_T] 3. PI: Vividrin Eye Drops, iNova Pharmaceuticals (Pty) Ltd:Date of registration: 08 May 1989 [https://drive.google.com/drive/u/0/folders/1f5LL9cR3RZIiFcqbP8n_NKfQxDg8ce_T] 4. Drugs.com: Cromolyn ophthalmic; Downloaded online 19 Nov 2018 [https://drive.google.com/drive/u/0/folders/1f5LL9cR3RZIiFcqbP8n_NKfQxDg8ce_T] 5. U2D: Cromolyn (sodium cromoglicate) (ophthalmic): Drug information; Uptodate; Downloaded online; 28 Nov 2018 https://www.uptodate.com/contents/cromolyn-sodium-cromoglicate-ophthalmic-drug-information? source=search_result&search=cromoglycic%20acid&selectedTitle=1~58 6. NAPOS The Drug Database for Acute Porphyria: Cromoglicic acid; Accessed online; 28 Nov 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=S01GX01&l=gbr] 7. South African Institute for Drug-Free Sport: Stop- Allergy; Accessed online; 28 Nov 2018 [http://www.drugfreesport.org.za/online-medication-check/] 8. PI - CROMOBEX_OPD - iPharma - Date of revision of text - 14 April 2023 - Downloaded online 08 June 2023 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/05/CROMOBEX_PI0001v1_14-04-2023SmPC-SAHPRA_Repository.pdf] 9. SmPC - Opticrom Allergy 2% w_v Eye Drops, Solution (Aspire MAH) - Summary of Product Characteristics Updated 09-Aug-2022 - SANOFI Consumer Healthcare - Downloaded online 08 June 2023 [https://www.medicines.org.uk/emc/product/9318/smpc] 10. SmPC - Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops Summary of Product Characteristics Updated 22-Sep-2022 | Rayner Pharmaceuticals Limited Downloaded online 09 June 2023 [https://www.medicines.org.uk/emc/product/560/smpc]

Brands & products

4 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days old

dropsGeneric· 4 products

from R6.65/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Stop allerg 13.5ml20 mg/ml13S2R86.49R6.65R41.81894605003
Vividrin eye drops20 mg/ml1S2R119.30R119.30R53.16804630003
Cromohexal 10ml10 ml1S1R128.88R128.88R56.47822698005
Cromabak 2% Eye Drops20 mg/ml1S2R155.06R155.06R65.53700864001
Trade names (3)
  • Bausch & Lomb Vividrin Eye Drops
  • Cromohexal Eye Drops
  • Stop-Allergy

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Cited in 1 document

NeoHealth® ID 16258 · updated 6/9/2023